1. Field of Invention
This invention relates generally to devices and methods for automating the distribution of regulated consumer products, in particular, pharmaceutical products that are regulated by the Drug Enforcement Agency (DEA), FDA, and other federal, state and local law enforcement organizations. More specifically, the invention relates to the automating the authorization, approval, and vending of products containing pseudoephedrine, making it easier for retailers to provide them directly to consumers under the current regulatory scheme. In some cases, this invention describes an automated capability for vending regulated products without contact between consumers and store personnel.
2. Background of the Invention
Recently, Congress passed the Combat Methamphetamine Epidemic Act (CMEA), in an attempt to address the diversion of pseudoephedrine-containing over-the-counter medicine products by drug dealers for use in manufacturing illegal substances. In implementing this law, the DEA has established constraints on the sale of products that contain pseudoephedrine and other chemicals. These constraints require pharmacies, drug stores, and convenience stores, among others, to validate the purchaser, regulate quantities, and maintain detailed logs of purchases. A consumer may only purchase certain limited amounts of pseudoephedrine in any one day, and/or over a one month time span, or other regulation-set time periods. In addition, certain states have regulations and laws that further regulate such sales. These regulations are designed to limit over the counter sales in an effort to reduce the amount of illegal substances that can be produced using pseudoephedrine as one of the essential ingredients. For retail establishments, implementing and complying with these new regulations as a business process can be expensive, tedious, and can force the business to spend significant amounts of labor time to ensure compliance with the various regulations, reducing the businesses' focus on their core processes. Not only do the retail locations spend significant time and resources implementing the required measures, but they also must keep detailed written records, such as logs, documenting each pseudoephedrine transaction. Therefore, there is a need to assist retail vendors of regulated products by limiting the cost and time required to properly and effectively comply with federal, local, or state regulations, particularly DEA regulations. In addition, manufacturers of over-the-counter medicine products containing pseudoephedrine (or other regulated products) need to effectively distribute their products within the regulatory framework so that their core business is preserved. Law enforcement agencies require effective analysis of purchasing data so that persons who divert such products to covertly manufacture illegal street drugs can be interdicted, in an effort to reduce the amount of pseudoephedrine containing products that are diverted into the illegal drug markets. And consumers who use these products lawfully need easier access, and more efficient methods of purchasing such regulated products.
A complicating factor is the diversity of regulations among the federal, state and local regions. For example, some states place an age restriction on purchasers and require that the retail vendor verify the purchaser's age. The DEA presently imposes a limit (expressed in milligrams of pseudoephedrine), which can be (and sometimes is) further limited by state or local regions. Some states further regulate the amount that can be purchased in any single day, or one month, periods of accounting.
The federal state and local agencies also need the ability to audit the log information to determine the retail store's compliance with applicable regulations. One way in which the regulations can be violated is for the lawbreaker to purchase over-the-counter pseudoephedrine products at a number of different stores, including those in different chains, and those in different regions, in an effort to avoid the daily or monthly limits. Thus, there is a need for an automated method of auditing the quantities purchased by anyone individual in local, state and federal jurisdictions.
U.S. Pat. No. 6,711,465 (Tomassi) disclosed vending machine systems and their associated methods of operation that are capable of verifying a consumer's identity. The vending machine systems include a card reader in conjunction with a biometric characteristic verifier that allows the device to verify a consumer's identity to assist in the purchase of regulated products, particularly cigarettes or alcohol. Tomassi disclosed vending embodiments capable of verifying whether the customer is old enough to purchase a product, but did not disclose methods for verifying compliance with other regulated parameters (such as cumulative purchase quantities), or methods of documenting a consumer's transaction. While Tomassi mentions pharmaceuticals, there are no methods disclosed for verifying whether the vending of pharmaceuticals would comply with applicable regulations, other than evaluating the age of the purchaser.
U.S. Published Patent Application US 2005/0192705 A1, filed by Pinney, et al, described an automated random access, random load storage and delivery unit capable of storing finished prescriptions and over the counter items. Pinney also described a communication network involving the random access, random load storage unit, a pharmacy management computer system, and a point of sale (“POS”) system. Pinney, however, did not disclose methods or algorithms that can be used to authorize a purchase of a regulated product in compliance with set regulations to determine whether that consumer's ability to purchase the regulated product at that time is authorized under applicable regulations.
The present invention overcomes these and other deficiencies of the prior art by providing various devices and methods for vending regulated products, including those containing pseudoephedrine, by automating the procedures necessary to comply with the various state and federal regulations, and providing more efficient methods of delivering regulated products to consumers, providing access to such products, and automating the record keeping required by many regulations.